This invention relates generally to the field of surgical appliances for draining bodily wastes through a surgically-created bodily opening. In particular, the invention relates to an appliance for draining a person's natural bladder, or a surgically-created artificial bladder, through an abdominal stoma.
A person may, because of injury, malignancy, birth defects, or nerve damage, suffer the loss of the bladder or loss or impairment of the bladder function. To provide urinary drainage for such a person, a urinary ostomy, or urinary diversion, must be performed, whereby an artificial bodily opening is provided for the outflow of urine.
A common urinary ostomy procedure is that which is frequently termed an "ileal conduit." This procedure, which is used when the bladder is removed or bypassed, involves the separation of a segment of the lower ileum, about six inches in length, with the blood supply intact. One end of the ileal segment is sutured shut; the other end is brought through the abdominal wall (usually in the lower right quadrant) to form an opening, or stoma, to the outside of the body. The ileal segment now forms an "ileal bladder", and the ureters, which convey urine from the kidneys to the bladder, are connected to the ileal bladder. The stoma thus forms a urinary passage from the ileal bladder to the outside of the body.
Another surgical procedure which is frequently performed is known as a cystostomy or a vesicostomy. In this procedure, an opening is made into the body and into the bladder, allowing the bladder to drain directly through a stoma, rather than through the urinary sphincter and the urethra. Still another procedure, known as a ureterostomy, involves detaching the ureters from the bladder and draining them into one or two abdominal stomas.
All of the above procedures result in a loss of voluntary control of the passage of urine. Therefore, drainage and collection devices must be used to contain the drained urine until it can be disposed of. Typical prior art devices include a tube, one end of which is inserted into the bladder (natural or artificial) through the stoma, with the other end draining into a removable collection device, such as a bag or a pouch. Frequently, an expandable elastic balloon (also known as an inflatable "cuff") surrounds the tube near its inner end. When inflated, the balloon forms a fluid seal around the tube at the opening of the bladder into the stoma, and further secures the tube against dislodgment. An early example of such a device is disclosed in French patent no. 676,943; a more modern version of this concept is embodied in the device which is well-known to medical practitioners as the Foley catheter.
These prior art devices have several drawbacks. For example, it is difficult with these devices to obtain a good, fluid-tight seal around the drainage tube within the bladder and within the stoma. This is largely a result of the uneven surface of the tissues involved, and the inability of the prior art devices to engage such tissues in a secure sealing contact, while being sufficiently gentle to avoid discomfort. As a result, leakage of urine around the tube is frequently a problem, leading to unpleasant odor, skin irritation, and, possibly, infection.
Another problem with prior art devices is that the inner tissues of the bladder can frequently come into contact with the inner end of the drainage tube. These tissues can, as a result, become painfully irritated. In the case of a natural bladder, encrustations and painful spasms can also result.
Still another problem with such devices is that they must frequently be secured to the outside of the body by adhesive tape, which can cause skin irritation, leading to possible infection. Yet another problem is that the attachment of the collection bag or pouch frequently requires the surgical formation of a "rosette" at the skin site around the stoma, thereby adding complexity and time to the surgical procedure involved.
All of these drawbacks make the prior art devices inconvenient, and frequently uncomfortable, to wear. Moreover, the need for frequent cleaning of the drainage device and the drainage site make removal of the device mandatory every two or three weeks, thereby contributing to the inconvenience of their use.
It will thus be appreciated that there is a need for a drainage device or appliance which overcomes the aforementioned drawbacks, and which therefore provides a conveniently used, comfortably worn means of voiding urinary wastes through a stoma, and which can be worn for extended periods of time without undue concern for leakage, irritation, or infection.